Kafensit

Kafensit

KAFENSİT

3ml N10

Ingredients

Active substance: 1 ml of solution contains 20 mg of caffeine citrate (equivalent to 10 mg of caffeine).

3 ml of solution contains 60 mg of caffeine citrate (equivalent to 30 mg of caffeine).

Excipients: monohydrate citric acid, sodium citrate dihydrate, water for injections.

Pharmacological properties

Caffeine is structurally related to other methylxanthines, theophylline and theobromine. Most of the effects are related to the antagonism of both adenosine receptor subtypes A1 and A2A, as shown in the receptor blocking tests and observed at concentrations close to the doses obtained therapeutically.

The main effect of caffeine is to stimulate the central nervous system. This is the main reason why caffeine affects premature apnea. Various mechanisms of action have been proposed for this purpose:

(1) stimulation of the respiratory center, (2) increased minute ventilation, (3) decreased hypercapnia threshold, (4) increased hypercapnia response, (5) increased skeletal muscle tone, (6) decreased diaphragmatic fatigue, (7) increased metabolism, and ( 8) increase in oxygen consumption.

The effect of caffeine begins a few minutes after the infusion.

Caffeine citrate spreads rapidly in the brain after administration. The concentration of caffeine in the spinal fluid of premature infants is close to plasma levels. Caffeine easily passes from the placenta into the bloodstream of the fetus and into breast milk.

In premature infants, caffeine metabolism is very limited due to underdeveloped liver enzymes, and most of the active substance is excreted in the urine. In the elderly, hepatic cytochrome P450 1A2 (CYP1A2) is involved in the metabolism of caffeine.

 

Instructions for use

It is used for short-term treatment of primary premature apnea in infants aged 28-33 weeks.

How to use and dosage

Treatment with caffeine citrate should be started under the supervision of an experienced physician in the intensive care of newborns. Treatment should be carried out only in the neonatal intensive care unit, which has the necessary conditions for the control and monitoring of patients.

The recommended dose regimen for previously untreated infants is a loading dose of 20 mg of caffeine citrate per kilogram of body weight, administered slowly intravenously over a period of more than 30 minutes using a syringe infusion pump or other sized infusion device. After a 24-hour break, a supportive dose of 5 mg per kilogram of body weight may be administered by slow intravenous infusion every 24 hours for more than 10 minutes. Alternatively, 5 mg of caffeine citrate per kilogram of body weight can be used orally (for example, with a nasogastric tube every 24 hours).

The recommended loading and storage doses of caffeine citrate are given in the table below, which clarifies the relationship between the injection volume and the administered dose.

The base dose of caffeine is half the dose when expressed as caffeine citrate (20 mg of caffeine citrate is equal to 10 mg of caffeine base). Caffeine citrate can be used as an intravenous infusion and orally. The drug should not be administered by intramuscular, subcutaneous, intrathecal or intraperitoneal injection.

Note:

Apnea

Premature apnea is diagnosed without other causes of apnea. Other causes of apnea (e.g., central nervous system disorders, primary lung disease, anemia, sepsis, metabolic disorders, cardiovascular abnormalities, or obstructive apnea) should be ruled out before treatment with caffeine citrate, or these causes should be treated properly. If this is insufficient for caffeine treatment (confirmed by measurement of plasma levels if necessary), it may be an indication of another cause of apnea.

Caffeine intake

In newborns born to mothers who received large amounts of caffeine before birth, the initial plasma concentration of caffeine should be measured before starting treatment with caffeine citrate, because caffeine easily passes from the placenta into the bloodstream of the fetus.

Mothers of newborns treated with caffeine citrate should not take caffeinated foods, beverages, or caffeinated medications because they are excreted in breast milk.

Theophylline

In neonates previously treated with theophylline, the initial plasma caffeine concentration should be measured before starting treatment with caffeine citrate, as theophylline is metabolized to caffeine in premature infants.

Convulsions

Caffeine is a central nervous system stimulant, and seizures have been reported with caffeine overdose. Caffeine citrate should be used with extreme caution in newborns with seizures.

Cardiovascular reactions

Published studies have shown that caffeine increases heart rate, left ventricular output and stroke volume. Therefore, caffeine citrate should be used with caution in newborns with known cardiovascular disease. There is evidence that caffeine causes tachyarrhythmias in sensitive people. In newborns, this is usually a simple sinus tachycardia. Caffeine citrate should be used with caution if the baby has an unusual arrhythmia on the cardiotocograph (CT) scan before birth.

Kidney and liver disorders

Caffeine citrate should be used with caution in premature infants with impaired renal or hepatic function. Doses should be adjusted to monitor plasma concentrations of caffeine to prevent toxicity in this population.

Necrotic enterocolitis

Necrotic enterocolitis is a common cause of morbidity and mortality in premature infants. There are reports of a possible association between the use of methylxanthines and the development of necrotic enterocolitis. However, a causal relationship between caffeine or other methylxanthine use and necrotic enterocolitis has not been evaluated. As with all preterm infants, infants treated with caffeine citrate should be closely monitored for the development of necrotic enterocolitis.

Caffeine citrate should be used with caution in patients with gastroesophageal reflux disease.

Caffeine citrate causes a general increase in metabolism, which can result in more energy and nutritional needs during treatment.

Diuresis and electrolyte loss caused by caffeine citrate may require correction of fluid and electrolyte disturbances.

Contraindications

High individual sensitivity to the drug or any of its components.

 

Pharmaceutical form,standard packaging

3 ml of solution in a colorless glass (Type I) vial with a Teflon-coated rubber stopper and a flip-off aluminum cap. 1 or 10 vials are packed in a cardboard box with a package insert.

Sold on by prescription.

Manufacturer

Idol Drug Filling Industry and Trade A.Ş., Turkey

Davutpaşa Street, Cebe Ali Bey Sokak, No: 20 Topkapı / İstanbul, Turkey

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